Injection Device with Electronic Detecting Means

ABSTRACT

An injection device for injecting a dose of drug, e.g. insulin for diabetes treatment, in which energy is stored in a spring member during dose setting. The stored energy is released and used for driving an injection mechanism during injection of a previously set dose. The injection device further comprises means for electronically detecting the amount of a set dose and/or means for electronically detecting the amount of an injected dose. The electronic detecting means allows storage and/or logging of data relating to injections performed using the injection device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 12/442,168 (Noticeof Allowance Received) filed Mar. 20, 2009, which is a 35 U.S.C. §371national stage application of International Patent ApplicationPCT/EP2007/060331 (published as WO 2008/037801), filed Sep. 28, 2007,which claimed priority of European Patent Application 06020547.3, filedSep. 29, 2006; this application further claims priority under 35 U.S.C.§119 of U.S. Provisional Application 60/851,523, filed Oct. 13, 2006;the contents of all the above-named applications are incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention relates to an injection device having a dosesetting mechanism, the operation of which causes energy to be stored ina spring member, i.e. a so-called ‘auto injection device’. Moreparticularly, the present invention relates to an injection device asdescribed above, and comprising electronic detection means for detectingthe amount of a set dose and/or the amount of an injected dose.

BACKGROUND OF THE INVENTION

Various injection devices have been described, which comprise energystoring means, such as a spring member, in which energy is stored duringdose setting. Subsequently, during injection of a previously set dose,energy stored in the energy storing means is released and used fordriving an amount of drug corresponding to the previously set dose outof the injection device.

Examples of such injection devices are shown in WO 2006/045528 and in WO2006/045529. The injection devices disclosed in WO 2006/045528 and in WO2006/034429 both comprise mechanical means, in the form of a doseindicator barrel, for detecting and displaying the amount of a set dose.During injection, the dose indicator barrel returns to its initialposition, and it is thereby also capable of indicating the amount of aninjected dose.

In some cases it may be desirable to store and/or log data relating tothe injections performed using the injection device, e.g. in order to beable to compare such data. However, it is undesirable if this results inan increased size of the injection device.

Furthermore, in some cases it is desirable to provide an electronicdisplay at an exterior part of the housing of the injection device fordisplaying various relevant parameters, such as set dose, injected dose,time lapsed since last dose was injected, kind of medicament containedin the device, etc. At the same time, it is desirable to be able tomonitor relevant parts of the injection device, in particular to monitormovements of such relevant parts, in order to obtain desired informationto be displayed at the display.

SUMMARY OF THE INVENTION

It is, thus, an object of the invention to provide an injection devicecomprising energy storing means as described above, and in which theaccuracy of detecting the amount of a set dose and/or the amount of aninjected dose is improved as compared to similar prior art injectiondevices.

It is a further object of the invention to provide an injection devicewhich provides the possibility of storing and/or logging data relatingto injections performed using the injection device without increasingthe size of the injection device as compared to similar prior artinjection devices.

According to the invention the above and other objects are fulfilled byproviding an injection device for injecting a dose of drug, theinjection device comprising:

-   -   a dose setting mechanism being operable to set a desired dose,        operation of said dose setting mechanism causing energy to be        stored in a spring member,    -   an injection mechanism comprising a piston rod adapted to        cooperate with a piston positioned in a cartridge containing a        drug to be delivered in order to cause a set dose to be        delivered from the cartridge via the injection device, said        injection mechanism being driven by releasing energy previously        stored in said spring member during dose setting,    -   means for electronically detecting the amount of a set dose        and/or means for electronically detecting the amount of an        injected dose, and    -   electronic display means for displaying a set dose and/or an        injected dose to a user.

The injection device according to the present invention is particularlysuitable for repetitive self injections, such as injections of growthhormone, or of insulin for treatment of diabetes, because the injectiondevice can be operated in an easy and intuitive manner, and it istherefore not necessary that the person operating the injection deviceis a medical staff member or similar. The injection device mayadvantageously have an elongated shape, i.e. the injection device may bea ‘pen-like’ injection device.

The dose setting mechanism is operable to set a desired dose. Thus, thedose setting mechanism is a mechanism which the user operates when he orshe wishes to set a dose to be injected. The dose setting mechanism maybe rotationally operable, i.e. it may comprise a member which the usermust rotate in order to set a dose, e.g. in the form of a dose knob.Alternatively, the dose setting mechanism may be substantially linearlyoperable. In this case the dose setting mechanism comprises a memberwhich the user must pull or push in a substantially linear movement inorder to set a desired dose.

Operation of the dose setting member causes energy to be stored in aspring member. This may, e.g., be achieved by compressing a compressiblespring member, by tensioning a torsion spring, or in any other suitablemanner. The important feature is that the spring member is capable ofstoring energy during dose setting and of releasing the stored energyduring injection of a set dose. Thereby the stored energy causes the setdose to be injected, i.e. it is not necessary for the user to applyfurther force or movement to the injection device during injection inorder to cause a set dose to be injected. This is an advantage becauseit ensures a very uniform delivery of the drug. It is also possible forthe user to keep the injection device more still during injectionbecause it is not necessary to move the fingers in order to cause thedose to be injected. Furthermore, it is possible to control theinjection speed, and the medication is thereby allowed to distribute ina more appropriate manner. Keeping the injection device still andcontrolling the injection speed both result in reduced pain experiencedby the user during injection. Furthermore, this is an advantage in thecase that the user has low dexterity or impaired finger strength,because in this case it may be difficult for the user to apply thenecessary force to the injection device in order to cause the set doseto be injected, thereby introducing the risk that an insufficient amountof drug is injected. This risk is eliminated in the injection deviceaccording to the present invention.

The injection device comprises means for electronically detecting theamount of a set dose and/or means for electronically detecting theamount of an injected dose. Thus, the injection device is capable ofkeeping track of the amount of a set dose, the amount of an injecteddose, or the amount of a set dose as well as the amount of an injecteddose. Furthermore, the detection is performed electronically rather thanmechanically, such as by means of a helically moving scale drum. As aconsequence, the detection may be performed very accurately.Furthermore, since there is no requirement of the presence of a scaledrum or other similar mechanical means for detecting the amount of a setdose and/or the amount of an injected dose, the injection device can bedesigned without consideration to the presence, accessibility and/orvisibility of such mechanical means. Thus, the injection device may bedesigned in a manner which provides optimization with regard to otherparameters, such as size, shape, user friendliness, etc. This is veryadvantageous.

The electronic display means may be or comprise an LCD display, an OLEDdisplay, an ELD display, a bi-stable e-ink display, or any othersuitable kind of display. Using an electronic display reduces the riskthat a user misreads a displayed number indicating a set or an injecteddose. This is very advantageous, since a misreading may lead to anincorrect dose being injected, and an incorrect dose may have severeconsequences to the person receiving the incorrect dose.

The means for electronically detecting the amount of a set dose and/orthe means for electronically detecting the amount of an injected dosemay be adapted to detect an angular displacement between at least twomembers, said angular displacement being indicative of the amount of aset dose and/or the amount of an injected dose. In this case one of themembers may be rotationally movable during dose setting and/or duringinjection, while another member remains substantially fixed, e.g.relatively to a housing of the injection device, during the sameoperation. Alternatively, at least two members may each be rotationallymovable, e.g. relatively to a housing of the injection device, either insuch a manner that they rotate in the same direction at differentangular velocities, or in such a manner that they rotate in oppositedirections. In any event, the movement of the members must result in arelative angular displacement, and the angular displacement must beindicative of the amount of a set dose and/or the amount of an injecteddose.

The means for electronically detecting the amount of a set dose and/orthe means for electronically detecting the amount of an injected dosemay comprise at least two substantially disc shaped members beingarranged with a substantially fixed mutual distance along a longitudinaldirection of the injection device, said substantially disc shapedmembers being rotationally movable relatively to each other during dosesetting and/or injection, and an angular displacement between saidsubstantially disc shaped members may in this case be indicative of theamount of a set dose and/or the amount of an injected dose. According tothis embodiment the relative movement between the disc shaped members ispurely rotational, i.e. the mutual distance along the longitudinaldirection is substantially fixed. The members may, alternatively, haveany other suitable shape other than disc shaped.

Alternatively, the mutual distance between the at least two members maybe variable during dose setting and/or during injection of a dose.

As an alternative to detecting the amount of a set dose and/or theamount of an injected dose by means of an angular displacement, theamount(s) may be detected by means of a relative linear displacementbetween two members. Similarly to what is described above, one or bothof the members may be linearly movable. It is also conceivable toprovide an injection device in which the amount of a set dose isdetected by means of a relative rotational displacement, and the amountof an injected dose is detected by means of a relative lineardisplacement, or vice versa.

The means for electronically detecting the amount of a set dose and/orthe means for electronically detecting the amount of an injected dosemay be adapted to detect the amount of a set dose and/or the amount ofan injected dose by measuring a capacitance. This may advantageously beobtained by providing a set of disc shaped members with a metal coating,thereby forming a set of electrodes when the disc shaped members arepositioned opposite each other, and thereby forming a capacitor. Byapplying the metal to the disc shaped members in a pattern which variesangularly, the area of the resulting capacitor will vary as a functionof relative angular displacement between the disc shaped members.Accordingly, since the capacitance, C, is given by

${C = \frac{ɛ_{0}A}{d}},$

where ε₀ is vacuum permittivity, A is the area of the capacitor, and dis the distance between the electrodes, the capacitance of the capacitorwill also vary as a function of the relative angular displacementbetween the disc shaped members.

Alternatively, the means for electronically detecting the amount of aset dose and/or the means for electronically detecting the amount of aninjected dose may be adapted to detect the amount(s) in any othersuitable manner, such as optically or inductively, e.g. using quadraturedetection. Detection using mechanical switches is also possible.

According to one embodiment, the injection device may comprise means forelectronically detecting the amount of a set dose, as well as means forelectronically detecting the amount of an injected dose, and the meansfor electronically detecting the amount of an injected dose may formpart of the means for electronically detecting the amount of a set dose.In this case the same detection means is used for detecting the amountof a set dose as well as the amount of an injected dose. This may, e.g.,be obtained using a single set of disc shaped members, as describedabove, being rotationally movable relatively to each other during dosesetting as well as during injection of a set dose.

Alternatively, the means for electronically detecting the amount of aset dose and the means for electronically detecting the amount of aninjected dose may be separate, e.g. in the form of two sets of discshaped members, as described above. In this case one set of disc shapedmembers will be rotationally movable relatively to each other duringdose setting, and the other set of disc shaped members will berotationally movable relatively to each other during injection of a setdose.

As an alternative, the injection device may comprise means forelectronically detecting the amount of a set dose only, and the amountof an injected dose may either not be detected or be detectedmechanically. Similarly, the injection device may comprise means fordetecting the amount of an injected dose only, and the amount of a setdose may be detected mechanically, e.g. using an ordinary scale drum.

The injection device may further comprise a release member for releasingenergy stored in the spring member, thereby causing a set dose to beinjected. The release member may, e.g., be or comprise a button whichthe user may press when the desired dose has been set and the injectiondevice has been arranged in such a manner that a dose can be deliveredat a selected and suitable injection site. The release member mayadvantageously be operatively connected to locking means which canmaintain the spring member in an energy storing position, e.g. a tensedposition, and the operation of the release member should, in this case,cause the locking means to be moved into a position in which it allowsthe stored energy to be released.

Preferably, the spring member is also arranged to store some amount ofenergy when no dose is set, i.e. the spring member is preferablypre-tensed to a certain degree. This is in order to ensure that theentire amount of a set dose is actually injected when the injectionmechanism is operated.

The spring member may be or comprise a torsion spring. Alternatively,the spring member may be or comprise a compressible spring, a leafspring, or any other suitable kind of spring being capable of storingand releasing energy. An embodiment comprising a compressible springwill be described in further detail below.

In the case that the spring member comprises a torsion spring, theinjection device may further comprise a nut positioned in an interiorpart of the injection device, said nut being movable during dose settingand during injection between a first position along a longitudinaldirection of the injection device, said first position corresponding toa maximum settable dose, and a second position along the longitudinaldirection of the injection device, said second position corresponding tocomplete injection of a previously set dose. According to thisembodiment the nut ensures that it is not possible to set a dose whichexceeds a maximum dose. The maximum settable dose may, e.g., be chosenso as to ensure that it is safe for the user to inject a set dose, e.g.so as to ensure that there will not be health hazards involved withinjecting a set dose. Furthermore, the nut provides an ‘end-of-dose’feature, i.e. when the nut is in the second position, the entire dosehas been injected, and this may even be communicated to the user, e.g.in a visual, audible and/or tactile manner.

As mentioned above, the spring member may be or comprise a compressiblespring, and the compressible spring may extend essentially along thelength of the injection device. In this case the injection devicepreferably has an elongated shape, i.e. the injection device ispreferably of a pen-like type. Thereby the direction in which theinjection device is elongated defines an axial direction, and thedimension of the injection device along this axial direction defines alength of the injection device. Thus, the compressible spring may extendessentially along this length, i.e. between a proximal end of theinjection device and a distal end of the injection device. Accordingly,the compressible spring is relatively long. Thereby it is possible tostore a sufficient amount of energy in the spring. Furthermore, thelonger the compressible spring is, the smaller a part of its totalworking range will be used when it is compressed to store energy. Thishas the consequence that a user will not be able to feel a difference inmechanical resistance from the spring at the beginning of dose settingand at the end of dose setting, and thereby the user will not experiencethat a spring is being compressed. The compressible spring may bearranged coaxially and surrounding one or more other longitudinal partsof the injection device, e.g. a dose rod and/or a piston rod.

According to one embodiment, the spring member may comprise two or morecompressible springs. In this case the spring members may be positioned‘side-by-side’, e.g. in parallel with a dose rod and/or a piston rod,thereby providing the possibility of designing the injection device witha relatively flat appearance without reducing the amount of energy it ispossible to store in the spring member.

The injection device may further comprise a spring compressing memberbeing movable along a longitudinal direction of the injection deviceduring dose setting and during injection, said spring compressing memberbeing positioned in abutment with the compressible spring, and thespring compressing member may be operatively connected to the dosesetting mechanism in such a manner that when the dose setting mechanismis operated the spring compressing member is caused to perform amovement along the longitudinal direction of the injection device,thereby compressing the compressible spring.

Thus, when the dose setting mechanism is operated, the springcompressing member is moved in such a manner that it causes compressionof the compressible spring. Thereby energy is stored in the compressiblespring. When it is at a later time desired to inject the set dose, thespring compressing member should be allowed to move in an oppositedirection, thereby allowing the energy stored in the compressible springduring dose setting to be released. According to one embodiment this maybe obtained in the following manner. The spring compressing member isconnected to another member via a thread connection. Rotating a doseknob in order to set a dose causes rotation of the spring compressingmember, and due to the thread connection, the spring compressing memberadditionally moves in an axial direction, thereby causing compression ofthe compressible spring. Furthermore, the spring compressing membershould be locked against a reverse movement at this stage, therebyensuring that the compressible spring remains compressed. When it isdesired to inject the set dose, a release mechanism is operated. Thiscauses a lock on the spring compressing member to be released, and thespring compressing member is thereby allowed to move backwards to itsinitial position in a substantially linear movement, e.g. while causingthe piston rod to cooperate with the piston of the cartridge to causethe set dose to be injected.

According to one embodiment the spring compressing member may be adaptedto rotationally abut an abutment member when a previously set dose hasbeen injected, said rotational abutment preventing further injection ofmedication, and the rotational abutment may be obtained by means of arotational movement of the spring compressing member and/or the abutmentmember. The rotational abutment provides a very precise indication ofwhen the entire dose has been injected, i.e. a very precise end-of-dosefeature. As mentioned above, the rotational abutment may be obtained byallowing rotation of the spring compressing member while the abutmentmember is kept substantially rotationally fixed, e.g. relatively to ahousing of the injection device. Alternatively, the abutment member maybe rotated while the spring compressing member is kept substantiallyrotationally fixed, or the spring compressing member as well as theabutment member may be rotated, preferably towards each other,relatively to a housing of the injection device.

The dose setting mechanism may comprise a dose knob which isrotationally operable, and rotational movement of said dose knob may inthis case cause energy to be stored in the spring member. According tothis embodiment, the energy is stored in the spring member as a resultof a rotational movement of the dose knob. The dose knob is preferably apart of the dose setting mechanism which is manually operable.

According to one embodiment, the means for electronically detecting theamount of a set dose and/or the means for electronically detecting theamount of an injected dose may be adapted to detect movements of amovable member being mechanically biased by a spring force. Thus, themovable member is a part of the injection device which is pre-stressedduring setting of a dose. Accordingly, the movements of a pre-stressedmember are being monitored for the purpose of electronically detectingthe amount of a set dose and/or the amount of an injected dose. This isadvantageous because a pre-stressed system tends to have less play thana system which is not pre-stressed, and thereby a more accuratedetection can be obtained. In embodiments where the movable member isthreadedly associated or engaged with other parts of the dosingmechanism, the pre-stressing of the movable member towards a particulardirection of revolution provides for improved rotational sensing of themovable member during dose setting and/or injection.

The movable member is preferably movable in at least two directions,e.g. two opposite angular movements or two opposite translationalmovements. In this case the spring force preferably acts in one of thesedirections.

The spring force may be provided by the spring member, and the movablemember may, in this case, be connected to the spring member in such amanner that the movable member is caused to move in response to energybeing stored in the spring member and/or in response to energy beingreleased from the spring member. In this case the spring force providedby the spring member is used for storing energy to be used duringinjection, as well as for mechanically biasing the movable member. As analternative, the spring force may be provided by a separate springmember.

The dose setting mechanism may comprise a click mechanism providingpositioning of a dose setting member in discrete steps during dosesetting. When a rotatable dose setting member is provided, the settingmember is then forced to move in incremental rotational steps, i.e.corresponding to pre-defined dosing steps. In the case that theinjection device comprises such a click mechanism as well as apre-stressed movable member as described above, a very accuratesynchronization between the discrete steps and the information presentedin the display can be obtained. Accordingly, the information presentedin the display, in this case, reflects the actual dose being set in avery accurate manner. This is very advantageous, because it is importantthat the set dose indicated in the display is the dose which is actuallybeing set, in order to avoid that a wrong dose is injected.

It should be noted, that a similar mechanism could be envisaged fordetecting the injected dose.

According to one embodiment, the means for electronically detecting theamount of a set dose and/or the means for electronically detecting theamount of an injected dose may be adapted to detect movements of amovable member, said movable member being connected to the spring memberin such a manner that the movable member is caused to move in responseto energy being stored in the spring member and/or in response to energybeing released from the spring member.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in further detail with reference tothe accompanying drawings in which

FIG. 1 is a perspective view of an injection device according to a firstembodiment of the invention,

FIG. 2 is a cross sectional view of the injection device of FIG. 1,

FIGS. 3-6 are partial views the injection device of FIGS. 1 and 2 atvarious stages of an injection operation,

FIG. 7 is an exploded view of electronic detection means for use in theinjection device of FIGS. 1-6,

FIG. 8 is an exploded view of the injection device of FIGS. 1-6,

FIG. 9 is a perspective view of an injection device according to asecond embodiment of the invention,

FIG. 10 is a cross sectional view of the injection device of FIG. 9,

FIGS. 11-14 are partial views of the injection device of FIGS. 9 and 10at various stages of an injection operation,

FIG. 15 is an exploded view of the injection device of FIGS. 9-14,

FIGS. 16-18 are cross sectional views of an injection device accordingto a third embodiment of the invention at various stages of an injectionoperation, and

FIGS. 19-21 are partial views of the injection device of FIGS. 16-18 andshown at the same stages of the injection operation.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an injection device 1 according to afirst embodiment of the invention. The injection device 1 comprises ahousing 2, a dose knob 3 positioned at a proximal end of the injectiondevice 1, and a portion 4 adapted to receiving an injection needlepositioned at a distal end of the injection device 1. The housing 2comprises a cartridge holding portion 5 and a portion 6 being providedwith a display 7 for displaying the amount of a set dose and/or theamount of an injected dose. Adjacent to the dose knob 3 an injectionbutton 8 is positioned. When it is desired to inject a dose, the doseknob 3 is rotated in order to set the desired dose, and subsequently,when an injection needle has been positioned at a suitable injectionsite, the injection button 8 is pressed, thereby causing the set dose tobe injected. This will be described further below.

FIG. 2 is a cross sectional view of the injection device 1 of FIG. 1.The injection device 1 comprises a torsion spring 9 arranged co-axiallywith and surrounding a threaded piston rod 10. When the dose knob 3 isrotated during dose setting, the torsion spring 9 is twisted, and energyis thereby stored in the torsion spring 9. This is obtained in thefollowing manner. The dose knob 3 is rotationally coupled to a ratchet11 during dose setting. The ratchet 11 is also connected to the torsionspring 9. Thus, rotating the dose knob 3 causes the ratchet 11 torotate, thereby tensioning the torsion spring 9. Furthermore, rotatingthe dose knob 3 causes nut 12 to travel in a direction towards the doseknob 3 via threaded connection 13. The nut 12 has a function which issimilar to the function of a scale drum in injection devices havingmechanical detection of the amount of a set dose, i.e. the axial andangular position of the nut 12 indicates the amount of a set dose.However, according to this embodiment of the invention, the nut 12 doesnot have the function of displaying the set dose, contrary to thefunction of an ordinary scale drum. It is, therefore, not necessary toposition the nut 12 in such a manner that it is readily visible.Accordingly, the nut 12 is positioned as shown in FIG. 2, i.e. in aninterior part of the injection device 1.

The injection device 1 is further provided with a set of disc shapedmembers 14 being adapted to rotate relatively to each other during dosesetting as well as during injection. The disc shaped members 14 are eachprovided with a layer of metal arranged in a pattern, and the discshaped members 14 thereby form a capacitor having a capacitance whichvaries as a function of a relative angular displacement between the discshaped members 14. Thereby the capacitance provides a measure for theangular displacement between the disc shaped members 14, and thereby forthe amount of a set or injected dose. This will be described in furtherdetail below.

Electronic circuitry (not shown) is adapted to read the capacitance fromthe disc shaped members 14 and to communicate a corresponding doseamount to the display 7, thereby causing the relevant dose amount to bedisplayed to a user.

Linear sensors are furthermore provided for monitoring axial movementsof specific parts of the injection device. The linear sensors may becapacitively based sensors of the type generally described in U.S. Pat.No. 5,731,707. During setting of a dose the disc shaped members 14reflects the angular position of the dose knob 3, and the axial positionof one or more of the linear sensors reflects the number of full turnsthe dose knob 3 has been dialled. Thereby the relative angular positionof disc shaped members 14 and the axial position of the linear sensor(s)in combination are used for electronically detecting the set dose, i.e.providing an absolute detection of the dose setting. A similararrangement could be used for providing an absolute detection of aninjected dose.

When it is desired to inject a previously set dose, injection button 8is pressed, thereby causing the ratchet 11 to be decoupled from thehousing 2. Thereby the ratchet 11 is allowed to rotate. The energystored in the torsion spring 9 during dose setting therefore forces theratchet 11 to rotate back to its initial position. The ratchet 11 isrotationally coupled to the piston rod 10, via injection ratchet 17(visible in FIGS. 5, 6 and 8), and the piston rod 10 will therefore alsorotate during this. Since the piston rod 10 is threadedly connected tothe housing 2, this rotation will cause the piston rod 10 to move in adirection towards the cartridge holding portion 5 of the housing 2. As aconsequence, an amount of drug corresponding to the previously set dosewill be injected from the injection device 1.

During injection the disc shaped members 14 perform a rotationalmovement relatively to each other, and the printed circuit 15 reads thecorresponding capacitance and causes a corresponding amount of injecteddose to be displayed in the display 7, similarly to the situation duringdose setting described above.

FIGS. 3-6 are partial views of the injection device 1 of FIGS. 1 and 2at various stages of an injection operation. For the sake of clarity,parts of the injection device 1 which are not necessary for describingthe injection operation have been omitted.

FIG. 3 shows the injection device 1 in an initial position, i.e. theinjection device 1 is ready for setting a dose. In order to set thedose, the dose knob 3 is rotated, thereby causing the torsion spring 9to be tensed, and the disc shaped members 14 to perform a rotationalmovement relatively to each other, as described above. Furthermore,printed circuit 15 a is caused to move in a distal direction, i.e. in adirection away from the dose knob 3, due to a connection between track18 on ratchet extension 19 and track 20 a arranged on the printedcircuit 15 a.

FIG. 4 shows the injection device 1 of FIGS. 1-3 in a position where adose has been set and the injection device 1 is ready for injection.When comparing FIG. 3 and FIG. 4 it is clear that printed circuit 15 ahas been moved in a distal direction. For the sake of clarity the doseknob is not visible. In order to initiate injection, the injectionbutton 8 is pressed. This causes the ratchet 11 to be decoupled from thehousing, thereby causing the energy previously stored in the torsionspring 9 to be released, the released energy rotorically driving theratchet 11 back. As a consequence the piston rod 10 is moved in a distaldirection as described above.

FIG. 5 shows the injection device 1 of FIGS. 1-4 during injection. It isclear from FIG. 5 that ratchet extension 19 has been moved in a distaldirection due to operation of the injection button 8.

FIG. 6 shows the injection device 1 of FIGS. 1-5 in a position whereinjection has been completed. Accordingly, printed circuit 15 a has beenmoved back to the position of FIG. 3. Comparing FIGS. 3 and 6 it isclear that injection button 8 is still in a pressed-down position inFIG. 6, indicating that the injection has only just been completed, andthat the injection device 1 is not yet ready for setting a new dose.Furthermore, it is clear that the piston rod 10 has been moved in adistal direction, indicating that a dose has been injected due tocooperation between the piston rod 10 and a piston positioned in acartridge containing the drug to be injected.

FIG. 7 is an exploded view of electronic detection means for use in theinjection device of FIGS. 1-6, in the form of a set of disc shapedmembers 14. The electronic detection means comprises two outer discs 21arranged with a third disc 22 there between. The third disc 22 isprovided with a pattern of metal which varies as a function of anangular position of the third disc 22. The outer discs 21 and the thirddisc 22 are able to rotate relatively to each other. Thereby, thecapacitor formed by the third disc 22 and at least one of the outerdiscs 21 has a capacity which varies as a function of the angulardisplacement between the outer discs 21 and the third disc 22.

In accordance with this first embodiment, the mechanism ensures that themoveable parts have a repeatable pattern of movement in such a way thatzero always represents the same rotational position. The electronicalreading can be made absolute, as opposed to a relative reading, therebyensuring a high security of operation.

FIG. 8 is an exploded view of the injection device 1 of FIGS. 1-6. Thus,FIG. 8 shows the individual parts of the injection device 1 in a clearmanner.

FIG. 9 is a perspective view of an injection device 1 according to asecond embodiment of the invention. The injection device 1 comprises ahousing 2 with a cartridge holding portion 5 and a portion 6 holding adisplay (not shown) arranged at 7′. At a distal end of the injectiondevice 1 there is a portion 4 for receiving an injection needle. Theinjection device 1 is further provided with a combined dose knob andinjection button 23. Thus the combined button 23 is rotated when it isdesired to set a dose, and it is pressed when it is desired to inject apreviously set dose.

FIG. 10 is a cross sectional view of the injection device 1 of FIG. 9.The injection device 1 according to this embodiment of the inventioncomprises a compressible spring 24 arranged coaxially with andsurrounding a threaded piston rod 10. The compressible spring 24 extendssubstantially along the entire length of the portion 6 of the housing 2which holds the display 7.

The injection device 1 further comprises a spring compressing member 25which is moved in a proximal direction during dose setting, therebycausing the compressible spring 24 to be compressed, thereby storingenergy in the compressible spring 24.

When it is desired to set a dose, the combined button 23 is rotated.This causes a dose rod 26 to rotate along. The dose rod 26 is connectedto the spring compressing member 25 in such a manner that the springcompressing member 25 is also caused to rotate along with the combinedbutton 23. The spring compressing member 25 is threadedly engaged withthe piston rod 10 which, on the other hand, is prevented from rotatingdue to first locking member 27, and from axial movement due to secondlocking member 28, also threadedly engaged with the piston rod 10.Accordingly, rotating the spring compressing member 25 results in thespring compressing member 25 moving along the thread of the piston rod10 in a proximal direction, thereby causing the compressible spring 24to be compressed.

When it is desired to inject a previously set dose, the combined button23 is pressed axially in a distal direction. Longitudinal member 30 ismoved along, thereby setting the second locking member 28 free to rotatein a manner which will be described in further detail below. Thereby thepiston rod 10 is allowed to move axially. The compressed spring 24 willthen push the spring compressing member 25 in a distal direction, andthe threaded connection between the spring compressing member 25 and thepiston rod 10 will cause the piston rod 10 to move in a distaldirection, thereby causing the set dose to be injected. When the setdose has been injected, the spring compressing member 25 will enter intoabutment with the second locking member 28, the second locking member 28thereby functioning as an abutment member, thereby preventing that adose exceeding the set dose is injected.

The injection device according to the shown embodiment is provided witha click mechanism providing audible and/or tactile clicks duringrotational operation of the combined button 23 so that each clickcorresponds to a pre-defined dose increment. Such click mechanismpreferably also provides positioning of combined button 23 in discreteoperational steps such as 24, 36 or 48 steps per revolution. In theshown embodiment, the click mechanism is provided by a stepped camsurface of combined button 23 which co-operates with a corresponding camsurface which is rotationally fixed with respect to the housing (bestseen in FIGS. 11-15). The two opposing cam surfaces are biased towardseach other by the compressible spring 24 causing the clicks to be veryself indexing and preventing that the system tends to run by it selfwhen resetting a dose.

FIGS. 11-14 are partial views of the injection device 1 of FIGS. 9 and10 at various stages of an injection operation, i.e. during setting of adose and injection of the set dose. For the sake of clarity, parts whichare not essential for the operation of the injection device 1 have beenomitted.

FIG. 11 shows the injection device 1 in a position where it is ready forsetting a dose. In order to set a dose, the combined button 23 isrotated as described above, thereby causing the dose rod 26, acting as aspring compressing member, to move in a proximal direction. During dosesetting, the second locking member 28 is in engagement with a set ofteeth 29 positioned on a longitudinal member 30 which is fixedrotationally to the housing. The second locking member 28 is therebyprevented from rotating relatively to the housing, and the piston rod 10is thereby prevented from moving axially relatively to the housing.

FIG. 12 shows the injection device 1 in a position where a dose has beenset and the injection device 1 is ready for injecting the set dose. Itis clear from FIG. 12 that the dose rod 26 has been moved in a proximaldirection. The second locking member 28 is still in engagement with theset of teeth 29, i.e. the piston rod 10 is still prevented from movingaxially relatively to the housing.

In order to cause the set dose to be injected, the combined button 23 ispressed, thereby pushing the longitudinal member 30 in a distaldirection. Thereby the set of teeth 29 is moved out of engagement withthe second locking member 28. Accordingly, the second locking member 28will be able to rotate relatively to the housing, and the piston rod 10will thereby be allowed to move axially relatively to the housing.

FIG. 13 shows the injection device 1 during injection of a previouslyset dose. It is clear from FIG. 13 that the second locking member 28 andthe set of teeth 29 are not engaging, and that the second locking member28 is therefore able to rotate relatively to the housing, therebyallowing axial movement of the piston rod 10. Accordingly, the pistonrod 10 is able to cause a set dose to be injected.

FIG. 14 shows the injection device 1 in a position where injection of aset dose has been completed. Comparing FIG. 11 and FIG. 14 it is clearthat the second locking member 28 is not in engagement with the set ofteeth (not visible in FIG. 14), and that the injection device 1 istherefore not yet ready for setting a new dose. Furthermore, the pistonrod 10 has been moved in a distal direction, indicating that a dose hasbeen injected.

FIG. 15 is an exploded view of the injection device of FIGS. 9-14. Thus,FIG. 15 shows the individual parts of the injection device 1 in a clearmanner.

It should be noted that in the embodiment shown in FIGS. 9-15 electronicdetection means are not shown. However, it is to be understood thatelectronic detection means being essentially identical to the ones shownin combination with the embodiment of FIGS. 1-8 could also be envisagedin the embodiment shown in FIGS. 9-15.

FIGS. 16-21 show various illustrations of an injection device 1according to a third embodiment of the invention. The injection device 1according to the third embodiment of the invention is operatedessentially as the injection device 1 according to the second embodimentwhich is described above with reference to FIGS. 9-15. Accordingly, theoperation of the injection device 1 according to the third embodiment ofthe invention will not be described in details here.

FIG. 16 is a cross sectional view of an injection device 1 according toa third embodiment of the invention. For the sake of clarity, only theportion 6 of the housing 2 which holds the display 7 is shown, thecartridge holding part being omitted. In FIG. 16 the injection device 1is shown in a position where it is ready for setting a dose.

The injection device 1 is provided with a first set of disc shapedmembers 31 arranged at a position near the combined button 23. The firstset of disc shaped members 31 functions essentially as the set of discshaped members 14 described above with reference to FIGS. 1-8. Thus,when the combined button 23 is rotated during dose setting the discshaped members 31 perform relative rotational movements, and thereby thecapacitance of the capacitor formed by the disc shaped members 31varies. Thereby the set dose can be electronically detected. This willbe described further below with reference to FIGS. 19-21.

The injection device 1 is further provided with a second set of discshaped members 32 arranged at a distal position of the portion 6 holdingthe display 7. The second set of disc shaped members 32 also functionsessentially as the disc shaped members 14 described above with referenceto FIGS. 1-8. During injection of a previously set dose the piston rod10 causes the second locking member 28 to rotate. Thereby the discs ofthe second set of disc shaped members 32 are caused to perform relativerotational movements, and thereby the capacitance of the capacitorformed by the disc shaped members 32 varies. Thereby the injected dosecan be electronically detected. This will be described further belowwith reference to FIGS. 19-21.

FIG. 17 is a cross sectional view of the injection device 1 of FIG. 16.However, in FIG. 17 a dose has been set, i.e. spring compressing member25 has been moved in a proximal direction, and thereby compressiblespring 24 has been compressed, i.e. energy has been stored in thecompressible spring 24.

FIG. 18 is a cross sectional view of the injection device 1 of FIGS. 16and 17. In FIG. 18 the set dose has been injected. It can be seen thatthe piston rod 10 has been moved in a distal direction as compared tothe situation shown in FIG. 16. Delivering of the dose has only justbeen completed. Thus, the combined button 23 is still in a pressed-downposition, thereby keeping the second locking member 28 and thelongitudinal member 30 out of engagement, the second locking member 28thereby being able to perform a rotational movement, allowing the pistonrod 10 to move in a distal direction.

FIGS. 19-21 are partial views of the injection device 1 of FIGS. 16-18at the stages of an injection operation which are also shown in theseFigures. For the sake of clarity, parts which are not essential for theoperation of the injection device 1 have been omitted.

FIG. 19 shows the injection device 1 in position where it is ready forsetting a dose, i.e. it corresponds to FIG. 16. In FIG. 19 printedcircuits 15 a and 15 b can be seen. During setting of a dose printedcircuit 15 a moves in a proximal direction in a similar manner to theone described above with reference to FIGS. 1-8. Thereby the set dose isdetected electronically in the following manner. The capacitance of thecapacitor formed by the first set of disc shaped members 31 reflects theangular position of the combined button 23, and the axial position ofthe printed circuit 15 a reflects the number of full turns the combinedbutton 23 has been dialled. Thereby the relative angular position of thefirst set of disc shaped members 31 and the axial position of theprinted circuit 15 a in combination are used for electronicallydetecting the set dose, i.e. providing an absolute detection of the dosesetting.

It should be noted that the set dose could in principle be detectedelectronically using only the first set of disc shaped members 31, i.e.without the use of printed circuit 15 a. Such an embodiment may includean electronic circuitry which electronically monitors the number ofcomplete revolutions that the combined button 23 undertakes duringoperation thereof, said monitoring being exclusively based upon signalsreceived from the first set of disc shaped members 31. Alternatively,the operation of the dose setting member is limited to 360 degreesoperation or less, such that any dose which it may be desired to set canbe set within a single turn of the combined button 23. Accordingly, asingle unit of a dose would, in this case, correspond to the combinedbutton 23 being rotated through a very small angle, and the first set ofdisc shaped members 31 would therefore need to be designed in such amanner that such small variations in relative angular position betweenthe discs are detectable.

FIG. 20 shows the injection device 1 in a position where a dose has beenset and is ready to be injected. Thus, FIG. 20 corresponds to FIG. 17.It can be seen that the printed circuit 15 a has been moved in aproximal direction relatively to the situation shown in FIG. 19.

When it is desired to inject the set dose, the combined button (notshown) is pressed in, and longitudinal member 30 is moved along in adistal direction. Thereby the set of teeth 29 formed on the longitudinalmember 30 are moved out of engagement with the corresponding set ofteeth formed on the second locking member 28, and the second lockingmember 28 is allowed to rotate as described above, thereby causing thediscs of the second set of disc shaped members 32 to perform relativerotational movements. Furthermore, the printed circuit 15 b is caused tomove axially in a distal direction. The axial position of the printedcircuit 15 b provides an indication as to whether the injection deviceis in dose setting mode or injection mode.

Finally, injection of a set dose causes printed circuit 15 a to move ina distal direction, thereby returning to the initial position.

FIG. 21 shows the injection device 1 in a position where a set dose hasjust been injected. Thus, FIG. 21 corresponds to FIG. 18. It can be seenthat the printed circuit 15 a has been returned to its initial position,and that the printed circuit 15 b has been moved in a distal direction.It can also be seen that the teeth 29 are still out of engagement withthe teeth of the second locking member 28.

In accordance with the embodiments described above, the disclosedmechanisms provide space efficient designs of spring assisted injectiondevices which makes room available for accommodating electroniccircuitry such as an electronic display, sensors etc. Particularly, thedesigns are suitable for injection devices having an electronic displaymounted fixedly with respect to the device housing while simultaneouslyproviding reliable routing of the wiring to the various sensorcomponents. In particular, the designs are optimized for spring assistedinjection devices where the sensing of rotational parts during both dosesetting and injection operations are made feasible.

1. An injection device for injecting a dose of drug, the injectiondevice comprising: a housing, a dose setting mechanism being operable toset a desired dose, operation of said dose setting mechanism causingenergy to be stored in a spring member, the dose setting mechanismdefining a first part that rotates during dose setting, an injectionmechanism comprising a piston rod adapted to cooperate with a pistonpositioned in a cartridge containing a drug to be delivered in order tocause a set dose to be delivered from the cartridge via the injectiondevice, said injection mechanism being driven by releasing energypreviously stored in said spring member during dose setting, theinjection mechanism defining a second part that rotates during doseinjection, means for electronically detecting the amount of a set dose,the means for electronically detecting the amount of a set dose beingadapted to detect an angular displacement between the first part and thehousing, means for electronically detecting the amount of an injecteddose, the means for electronically detecting the amount of an injecteddose being adapted to detect an angular displacement between the secondpart and the housing, and electronic display means for displaying a setdose and/or an injected dose to a user.
 2. An injection device accordingto claim 1, wherein the means for electronically detecting the amount ofa set dose are separate from the means for electronically detecting theamount of an injected dose.
 3. An injection device according to claim 1,wherein the means for electronically detecting the amount of a set doseand/or the means for electronically detecting the amount of an injecteddose is/are adapted to detect an angular displacement between at leasttwo members, said angular displacement being indicative of the amount ofa set dose and/or the amount of an injected dose.
 4. An injection deviceaccording to claim 3, wherein the means for electronically detecting theamount of a set dose and/or the means for electronically detecting theamount of an injected dose comprise(s) at least two substantially discshaped members being arranged with a substantially fixed mutual distancealong a longitudinal direction of the injection device, saidsubstantially disc shaped members being rotationally movable relativelyto each other during dose setting and/or injection, and wherein anangular displacement between said substantially disc shaped members isindicative of the amount of a set dose and/or the amount of an injecteddose.
 5. An injection device according to claim 1, wherein the means forelectronically detecting the amount of a set dose and/or the means forelectronically detecting the amount of an injected dose is/are adaptedto detect the amount of a set dose and/or the amount of an injected doseby measuring a capacitance.
 6. An injection device according to claim 1,wherein the means for electronically detecting the amount of a set doseand/or the means for electronically detecting the amount of an injecteddose is/are adapted to detect the amount of a set dose and/or the amountof an injected dose by using mechanical switches.
 7. An injection deviceaccording to claim 1, further comprising a release member for releasingenergy stored in the spring member, thereby causing a set dose to beinjected.
 8. An injection device according to claim 7, and furthercomprising locking means adapted to maintain the spring member in anenergy storing position, wherein the release member is operativelyconnected to the locking means so that operation of the release membercauses the locking means to be moved into a position allowing the storedenergy of the spring member to be released.
 9. An injection deviceaccording to claim 8, wherein the locking means comprises a rotatablelocking member, the rotatable locking member being associated with thepiston rod, wherein the rotatable locking member is prevented fromrotating relative to the housing during dose setting while being allowedto rotate during dose injection upon operation of the release member.10. An injection device according to claim 9, wherein the means forelectronically detecting the amount of an injected dose is adapted todetect an angular displacement between the rotatable locking member andthe housing.
 11. An injection device according to claim 7, wherein thespring member is or comprises a torsion spring.
 12. An injection deviceaccording to claim 11, further comprising a nut positioned in aninterior part of the injection device, said nut being movable duringdose setting and during injection between a first position along alongitudinal direction of the injection device, said first positioncorresponding to a maximum settable dose, and a second position alongthe longitudinal direction of the injection device, said second positioncorresponding to complete injection of a previously set dose.
 13. Aninjection device according to claim 7, wherein the spring member is orcomprises a compressible spring.
 14. An injection device according toclaim 13, wherein the compressible spring extends essentially along thelength of the injection device.
 15. An injection device according toclaim 13, and further comprising a spring compressing member beingmovable along a longitudinal direction of the injection device duringdose setting and during injection, said spring compressing member beingpositioned in abutment with the compressible spring, wherein the springcompressing member is operatively connected to the dose settingmechanism in such a manner that when the dose setting mechanism isoperated the spring compressing member is caused to perform a movementalong the longitudinal direction of the injection device, therebycompressing the compressible spring.
 16. An injection device accordingto claim 15, wherein the spring compressing member is adapted torotationally abut an abutment member when a previously set dose has beeninjected, said rotational abutment preventing further injection ofmedication, wherein the rotational abutment is obtained by means of arotational movement of the spring compressing member and/or the abutmentmember.
 17. An injection device according to claim 1, wherein the dosesetting mechanism comprises a dose knob which is rotationally operable,and wherein rotational movement of said dose knob causes energy to bestored in the spring member.
 18. An injection device according to claim17, wherein the dose setting mechanism comprises a click mechanismproviding positioning of the dose knob in discrete steps during dosesetting.
 19. An injection device according to claim 1, wherein the meansfor electronically detecting the amount of a set dose and/or the meansfor electronically detecting the amount of an injected dose is/areadapted to detect movements of a movable member being mechanicallybiased by a spring force.
 20. An injection device according to claim 19,wherein the spring force is provided by the spring member, the movablemember being connected to the spring member in such a manner that themovable member is caused to move in response to energy being stored inthe spring member and/or in response to energy being released from thespring member.